What you become a part of:
You will be part of the Quality Assurance (IPQA) function in a pharmaceutical manufacturing setup. This role plays a vital part in ensuring that all in-process checks are performed in accordance with cGMP, SOPs, and regulatory standards, thereby contributing to consistent product quality and patient safety.
What to expect:
· Preparation and timely updation of IPQA-related Standard Operating Procedures (SOPs) based on regulatory or operational requirements.
· Monitoring of raw material dispensing activities to ensure adherence to GMP practices and SOPs.
· Performing routine in-process quality assurance (IPQA) activities at designated frequencies, as defined in SOPs, and ensuring timely compliance of all IPQA observations.
· Conducting validation sampling as per the approved validation protocols and guidelines.
· Reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for accuracy, completeness, and readiness for dispatch.
· To check BSR and Shipper inspection as per SOP (as per requirement).
· Issuance, review, and reconciliation of formats for all departments.
· Issuance of BMR, BPR to the production department for processing of batch as per requisition received from production.
· Filing, labelling, and upkeep of documents in the document cell.
· To ensure cleaning, sanitation & hygiene in all departments and ensure all the time GMP compliance of plant.
· To handle IPQA team and related work allocation.
· To prepare monthly report of IPQA section related activity.
Essential education, experience and skills:
- B. Pharm and M. Pharm
- 8–10 years of experience in IPQA or Quality Assurance in a regulated pharmaceutical manufacturing environment.
- Should have exposure of SAP & ERP.
- Good understanding of cGMP, GLP, and regulatory requirements (e.g., USFDA, WHO, EU GMP).
- Proficiency in documentation practices, SOP handling, and batch record review.
- Strong attention to detail, ability to work in a team, and effective communication skills.
Application:
If this role is of interest to you, please upload a recent copy of your CV and a member of the Talent
Acquisition team will be in touch.
Salary
Competitive
Monthly based
Location
Pune, Maharashtra, India
Pune, Maharashtra, India